Model Number 10-80-00 |
Device Problems
Failure to Pump (1502); Device Displays Incorrect Message (2591)
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Patient Problem
No Patient Involvement (2645)
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Event Date 08/07/2017 |
Event Type
malfunction
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Manufacturer Narrative
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There was no patient involvement.Livanova (b)(4) manufactures the s5 roller pump.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not returned.
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Event Description
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Livanova (b)(4) received a report that the s5 roller pump displayed an error message and the pump motor failed during setup.The device was restarted and the failure did not recur.There was no patient involvement.
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Manufacturer Narrative
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A livanova field service representative called the customer and provided technical support.The reported issue could not be reproduced and no problem could be found.As the issue could not be reproduced or confirmed, a root cause was not identified.
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Search Alerts/Recalls
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